20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRAVERSE OCT SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 12, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 23, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·April 16, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 1, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 1, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·February 14, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2018
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
FDA 510(k)
FDA Class 2
·General Hospital
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
AGILITY HYDROPHILIC STEERABLE GUIDEWIRES
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code DQX·April 19, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·June 18, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015